| Primary Device ID | 20817038020542 |
| NIH Device Record Key | 631f5b54-e560-4272-9d6e-d21a68b0f6db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Multiple Drug Screen Cups |
| Version Model Number | U-CUP-8124 |
| Catalog Number | U-CUP-8124 |
| Company DUNS | 163610020 |
| Company Name | UCP BIOSCIENCES, INC. |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817038020548 [Unit of Use] |
| GS1 | 10817038020545 [Primary] |
| GS1 | 20817038020542 [Package] Contains: 10817038020545 Package: case [8 Units] In Commercial Distribution |
| DKZ | Enzyme Immunoassay, Amphetamine |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-05-24 |
| Device Publish Date | 2016-08-30 |
| 20817038022249 - inSight 12 Panel Drug Test Cup | 2024-05-24 inSight 12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC |
| 20817038022225 - OEM 81-13 Drug Test 5 Panel Test Cup | 2024-04-17 OEM 81-13 Drug Test 5 Panel Test Cup AMP/COC/THC/MET/BZO |
| 20817038022232 - OEM 81-13 Drug Test 6 Panel Test Cup | 2024-04-17 OEM 81-13 Drug Test 6 Panel Test Cup AMP/COC/THC/MET/BZO/OPI |
| 20817038022218 - u-CardTM Drug Test Screen 12 Panel Test Card | 2024-01-12 u-CardTM Drug Test Screen 12 Panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC |
| 20817038022201 - UCP | 2023-12-18 UCP Drug Test Mini Cups 9-Panel Drug Test Mini Cup AMP/BAR/BZO/COC/MDMA/MTD/OPI/PCP/PPX |
| 20817038021020 - UCP Home Pregnancy Dip Card | 2023-07-06 Pregnancy Dip Card |
| 20817038021211 - UCP HOME | 2023-07-06 UCP HOME Pregnancy Test Strip |
| 20817038021266 - UCP Home | 2023-07-06 UCP HOME Pregnancy Test Strip |